Leqvio (inclisiran)

Leqvio (inclisiran) is covered for adults (≥18) with HeFH or clinical ASCVD as an adjunct to diet and maximally tolerated statin therapy to lower LDL‑C, with approvals for 12 months and dosing per label (284 mg SC at baseline, 3 months, then every 6 months). Coverage requires documented diagnosis (HeFH via untreated LDL‑C ≥190 mg/dL, genetic confirmation, or Dutch/Simon Broome criteria, or documented ASCVD), prior trial of a high‑intensity statin and high‑intensity statin + ezetimibe for ≥8 weeks (or narrowly defined statin intolerance), post‑treatment LDL‑C ≥70 mg/dL, prescription/consultation by a cardiologist/endocrinologist/lipid specialist, and documented LDL (or lipid) response for reauthorization; no approval if criteria are unmet.

"Leqvio is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults who are diagnosed with the following and require additional lowering of low-density lipo..."